Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2014-06-30
2015-02-28
Brief Summary
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Detailed Description
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Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12 weeks.
Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the first months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the third month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peginterferon ,Ribavirin
drug :Peginterferon, Ribavirin,
Peginterferon, Ribavirin
Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.
Peginterferon, Ribavirin, camel milk
drug :Peginterferon, Ribavirin, camel milk
Peginterferon, Ribavirin, camel milk
Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .
camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.
Interventions
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Peginterferon, Ribavirin, camel milk
Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .
camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.
Peginterferon, Ribavirin
Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age age groups (18 to 70 years)
Exclusion Criteria
* Hx of HCC(hepatocellular carcinoma )
* Hx of alcoholic liver disease
* Hx of bleeding from esophageal varices
* Hx of hemochromatosis
* Hx of autoimmune hepatitis
* Hx of Suicidal attempt
* Hx of cerebrovascular dis
* Hx of severe retinopathy
* Hx of severe psoriasis
* Hx of scleroderma
* Hx of metabolic liver disease
* Hx of SLE(systemic lupus erythematosus )
18 Years
70 Years
ALL
No
Sponsors
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Mashhad University of Medical Sciences
OTHER
Responsible Party
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mohammadreza noras
Phd student
Principal Investigators
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Seyyd Musa Al-Reza Hosseini, professor.As
Role: STUDY_CHAIR
Ghaem Gastrointestinal Clinic
Mehdi Yousefi, MD.Phd
Role: STUDY_DIRECTOR
Faculty of Traditional Medicine Clinic
Mohammadreza Noras, Phd student
Role: PRINCIPAL_INVESTIGATOR
Faculty of Traditional Medicine Clinic
Ali Taghipour, MD.Phd
Role: STUDY_DIRECTOR
MUMS Faculty of Health Sciences
Said Zibae, MD.Phd
Role: STUDY_DIRECTOR
Razi vaccine and serum Research Institue of Mashhd
Locations
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Faculty of Traditional Medicine
Mashhad, Razavi Khorasan Province, Iran
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, Iran
Countries
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Other Identifiers
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Mashhad UMS
Identifier Type: -
Identifier Source: org_study_id
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